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FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A DENTIST OR PHYSICIAN OR OTHER LICENSED MEDICAL PRACTITIONER...
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WARNINGS & CAUTIONS Failure to comply with precautions and warnings described in this User Manual may lead to exposure to dangerous optical radiation sources. Please comply with all safety instructions and warnings. CAUTION: Read these instructions carefully prior to using your Gemini EVO 810+980 soft tissue diode laser. CAUTION: Ensure that all users are properly trained prior to use.
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WARNINGS & CAUTIONS WARNING: Visible and Invisible Laser Radiation – Avoid eye or skin exposure to direct or scattered radiation. Class IV Laser Product WARNING: Laser Safety Eye Protection MUST BE WORN by the Operator, Patient, Assistant, and anyone present when the laser is activated. Eye Protection must conform to Specification DIN EN207 Annex II of the Directive 89/686/EEC with wavelength protection of 810nm- 980nm, and ±10nm of OD 5+.
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WHAT IS IN THE BOX The Gemini EVO 810+980 soft tissue laser includes the following. Laser Unit Activation Pedal with 2 AA Batteries Fiber Delivery System *Actual Power supply may vary from image *Actual eyewear may vary from image Pre-Initiated Disposable Tips (10) *DC Power Supply *Protective Eyewear (x3) Bending tool included in the tip box...
OVERVIEW - LASER UNIT Transparent Display Base Magnetic Handpiece Holder Emergency Stop Optical Fiber LED Tip Strain Relief ON/OFF Guided Touch Interface Mini USB (factory use only) Surgical Handpiece External Power Supply Plug Remote Interlock Port Optical Fiber with Protection Tube...
OVERVIEW - ACTIVATION PEDAL Battery Compartment Lid Pedal Status Indicators Overstep/Shroud Protection AA Batteries (x2) Activation Area Label / Anti Skid Areas Battery Indicator Bluetooth B A T T E R Y L A S E R B L U E T O O T H L E V E L A C T I V E C O N N E C T I O N...
OVERVIEW - FIBER DELIVERY SYSTEM The Fiber Delivery System is a unique and ergonomic optical cable that is non-detachable from the Laser Unit. The handpiece will require cleaning and sterilization after each patient treatment. Disposable tips are intended for single-use only and must be disposed of after each patient use. Refer to pages 46-48 for cleaning and sterilization procedures.
QUICK START Download the mobile App Plug In Power Supply During initial setup use the AC/DC power supply for at least one hour to fully charge the battery. Plug the power supply into an AC outlet and connect to the corresponding connector on the rear of the system.
CONTROLS, OPERATION & USE 01 - ELECTRONIC KEY PASSCODE The Gemini EVO 810+980 soft tissue laser is equipped with an electronic key passcode. When you turn the Laser Unit on, the passcode key screen will be displayed at the bottom center of the screen. The correct passcode sequence should be entered on the Guided Touch Interface: UP, DOWN, UP, DOWN The Gemini EVO 810+980 soft tissue laser is equipped with Guided Touch Interface “GTI”...
CONTROLS, OPERATION & USE 02 - SELECTING A WAVELENGTH When the system is turned on, and the electronic passcode is properly input (Page 14), you will be prompted with voice confirmation “Please select wavelength” and two flashing wavelength graphics to select the desired wavelength of choice.
CONTROLS, OPERATION & USE 03 - ACTIVATION PEDAL CONNECTION Connecting the Activation Pedal with your Laser Unit via Bluetooth for the first time is simple. 8 1 0 9 8 0 Install the provided 2 AA batteries Turn the laser unit ON Enter the Passcode D U A L 8 1 0...
CONTROLS, OPERATION & USE 04 - MANUAL POWER ADJUSTMENT The Gemini EVO 810+980 soft tissue laser can output up to a maximum of 2.0 watts of average power. To adjust the power setting manually, touch the LEFT and RIGHT arrows on the Guided Touch Interface. Each touch of an arrow raises or lowers the power by 0.1 watts.
CONTROLS, OPERATION & USE 05 - LASER STBY AND ACTIVE MODES The Active/STBY Guided Touch Interface selection serves a dual purpose. It activates (ACTIVE) and deactivates the laser (STBY). By default, the system powers up in STBY mode. The laser cannot be activated prior to selecting a wavelength.
CONTROLS, OPERATION & USE 06 - PRESET PROCEDURE SETTINGS AND CUSTOMIZATION Touch the PRESET selection to bring up all the preset procedures and categories on the display. A collection of pre- programmed procedures will be revealed on the display. Selecting the LEFT and RIGHT arrows will toggle between NON SURGICAL, SURGICAL, and PAIN RELIEF categories.
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CONTROLS, OPERATION & USE PRESET PROCEDURE SETTINGS AND CUSTOMIZATION The Gemini EVO 810+980 soft tissue laser is pre-programmed with 16 procedures listed under three categories: NON SURGICAL, SURGICAL, and PAIN RELIEF. Within each category are the most commonly used procedures with suggested power settings.
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CONTROLS, OPERATION & USE PRESET PROCEDURE SETTINGS AND CUSTOMIZATION Gemini EVO 810+980 soft tissue laser preset procedure settings can be customized. To save your own procedure setting, press PRESET once to bring up preset procedures on the display and navigate to the procedure you would like to customize. Power bar Indicator and power value will start flashing on the display.
CONTROLS, OPERATION & USE 07 - TIP ILLUMINATION The Gemini EVO 810+980 soft tissue laser handpiece is equipped with a tip illumination light to provide better visibility of the surgical site during treatment. To toggle the light intensities between LOW, MEDIUM, HIGH, and OFF, touch the MENU icon and select TIP LIGHT on the Guided Touch Interface.
CONTROLS, OPERATION & USE 09- SOUND To change the sound level, touch the MENU and then the SOUND icon on the Guided Touch Interface. Adjust the sound level by touching the Up / Down arrows. To exit, touch the MENU icon to save your selection. The system remembers the last used sound setting when it is powered on.
CONTROLS, OPERATION & USE 11 - PHOTOBIOMODULATION (PBM) / WARNINGS & CAUTIONS CAUTION: Do not connect or disconnect a PBM adapter while the Gemini EVO laser is turned on. Only connect or disconnect a PBM adapter when the Gemini EVO laser is inactive or standby mode. CAUTION: Do not use any harsh chemicals or abrasives to clean the glass optics within a PBM adapter.
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CONTROLS, OPERATION & USE PBM COMPONENTS 7 mm Adapter 25 mm Spacer 25 mm Adapter 3 mm Adapter 3 mm and 7 mm PBM adapters can be used intraorally PBM ASSEMBLY (Attachment threading procedure applies to all PBM tips equally) 1.
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CONTROLS, OPERATION & USE SELECTING AND ADJUSTING PBM PRESET To enable Pain Relief, select PRESET on the Guided Use the UP / DOWN arrow to select Touch Interface and navigate with the right arrow the desired PBM adapter. to the PAIN RELIEF category. Click ACTIVE to select treatment time in seconds.
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CONTROLS, OPERATION & USE USE RECOMMENDATIONS Affected muscles and/or joints have to be exposed to an adequate level of laser energy over a period of time to provide effective results. Some cases may require more than one laser treatment, or a series of treatments, before significant improvement is reported.
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CONTROLS, OPERATION & USE PBM ADVERSE EVENTS & CONTRAINDICATIONS • Avoid treatment sites with tattoos. • Different implant materials will respond differently to laser energy and heat; be aware of any implants and their location; avoid direct exposure to laser energy or heat at the site of the implant. •...
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CONTROLS, OPERATION & USE PBM ADAPTER SPECIFICATION 25 mm PBM Adapter 7 mm PBM Adapter 3 mm PBM Adapter Dimensions 63 x 41 x 41 mm 100 x 24.7 x 14.9 mm 100 x 20.5 x 14.9 mm Weight 76 grams 50 grams 50 grams Spot Size...
CONTROLS, OPERATION & USE 12 - DISPOSABLE TIP OPERATION The disposable fiber tip is relatively flexible, but can be broken if bent at an angle that is too sharp. Use the provided bending tool to bend the tip to the desired angle. Do not bend the tip any more than the bending tool allows. Protein debris from gingival tissue accumulates on the fiber tip during surgery and the heat that develops will deteriorate the optical efficiency.
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CONTROLS, OPERATION & USE DISPOSABLE TIPS Gemini EVO laser’s single-use 5 mm fiber tips are unique in that they come pre-initiated. That means there is black pigment added to the end of each fiber tip to help focus laser energy at the tip. All procedures that require the removal or cutting of soft tissue require an initiated tip.
CONTROLS, OPERATION & USE 13 - BATTERY and BATTERY LEVEL INDICATIONS The Gemini EVO 810+980 soft tissue laser is equipped with a Lithium-Ion battery capable of delivering a full day of laser usage. Simply connect the provided power supply to the rear of the unit and charging will start immediately. It is recommended to fully charge the laser unit prior to initial use after unpacking.
CONTROLS, OPERATION & USE 15 - FIBER WRAPPING A fiber wrapping system was built within the Laser Unit in order to provide a safe and convenient way to manage and store the optical fiber system. To store the fiber properly, always wrap in a clockwise direction to protect and store the fiber optic cable when not in use.
CONTROLS, OPERATION & USE 16 - HANDPIECE MAGNET The Gemini EVO 810+980 soft tissue laser is designed with a magnet that will secure the surgical handpiece in place when the laser is not in use. Gently place the handpiece behind the transparent display or over the “rounded pad” of the laser unit and the magnet will hold the handpiece in place.
CONTROLS, OPERATION & USE 18 - EMERGENCY STOP The Gemini EVO 810+980 soft tissue laser can be immediately deactivated in any mode, at any time, and in any power setting by pressing the red STOP button located in the front left of the system. 19 - REMOTE INTERLOCK (Switch not Included) The Gemini EVO 810+980 soft tissue laser provides a remote interlock feature that enables a clinician to establish a dedicated laser treatment room with a remote interlock connector.
CONTROLS, OPERATION & USE 20 - ADD NEW ACTIVATION PEDAL - BLUETOOTH CONNECTION In certain instances, your office may need to have an additional Activation Pedal with the same Gemini EVO device. You can order an additional Activation Pedal and follow the instructions below to properly pair the new pedal with your Gemini EVO unit.
CONTROLS, OPERATION & USE 21 - TRANSPARENT ELECTROLUMINESCENT DISPLAY The Gemini EVO 810+980 soft tissue laser is designed with transparent electroluminescent display that can provide high resolution viewing angles from up to 160 degrees of field of view. The transparent display was specially designed with over 80% transparency and an arch of 15 degrees for optimal viewing angle from any direction.
MOBILE APP & DASHBOARD 22 - ENABLING WI-FI CONNECTIVITY VIA APP The Gemini EVO 810+980 soft tissue laser enables you to bridge your location’s existing Wi-Fi network directly to the Gemini EVO unit. This provisioning enables your Gemini EVO unit to receive internet connection, allowing the user to receive important performance updates, technical support, track procedures, and a multitude of other features.
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MOBILE APP & DASHBOARD Selecting a Wi-Fi network Office 2.4Ghz A list of Wi-Fi networks will be displayed. Please select the Wi-Fi network associated Office 5.0Ghz to your office location and enter appropriate password. Please note the Gemini EVO Starbucks Coffee Free Laser Wi-Fi is compatible with 2.4 GHz networks only.
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MOBILE APP & DASHBOARD Updates Devices With the iOS and This page will enable Android App, you can you to add or remove perform automatic a Gemini EVO device updates directly to from your registered your Gemini EVO account. You can laser.
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MOBILE APP & DASHBOARD Warranty Statistics With the iOS and With the Gemini Andriod apps, EVO app, you can you can purchase track how many extended warranty if procedures have qualified. The Gemini been performed by EVO laser comes category, see which with 2 years limited wavelength mode factory warranty.
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MOBILE APP & DASHBOARD WEB INTEGRATION VIA THE DASHBOARD Once connected to Wi-Fi, the GEMINI EVO 810+980 Soft Tissue Laser will share data with the DASHBOARD, which will enable you to visualize several parameters of your laser. In order to get access to the Dashboard, the user must have completed the registration process via the iOS or Android App.
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MOBILE APP & DASHBOARD DASHBOARD 01 - Pre-Set vs Manual 06 - Top 10 Preset Procedures This feature shows graphically the procedures performed This feature shows the top procedures performed by name manually vs with pre-sets. This is a good way to visualize and by category.
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MOBILE APP & DASHBOARD DASHBOARD - VITALS - UNIT SPECIFIC The vitals page will display specific information about your Gemini EVO device by unique serial number. This type of information is helpful while troubleshooting or visualizing a feature when the user has a functionality issue. 01 - Battery Health displayed.
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MOBILE APP & DASHBOARD DASHBOARD - CUSTOMIZE The customization page enables you to customize settings on your Gemini EVO device. 01 - Registered User 05 - Custom Presets This is where you can change your registered name and Your Gemini EVO comes with preset procedures settings phone number.
CLEANING AND STERILIZATION PROCEDURES GUIDELINES The Gemini EVO™ 810 + 980 Soft Tissue Laser is not supplied in sterile condition, nor must it be sterilized before use with the exception of the handpiece, 3 mm PBM, and 7 mm PBM tips. The following cleaning and sterilization procedures are recommended before the initial use and after each subsequent use: 1.
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CLEANING AND STERILIZATION PROCEDURES STEAM STERILIZATION The steam sterilization process is intended to destroy infectious microorganisms and pathogens. Always perform the sterilization procedure immediately after cleaning and prior to use, and only use FDA-cleared (USA) or CE-marked (Europe) sterilization accessories such as sterilization pouches and autoclave trays. 1.
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CLEANING AND STERILIZATION PROCEDURES Remove / reassemble the handpiece shell or 3mm/7mm PBM adapter following the instructions below. 7mm PBM Tip turn counter clockwise to remove it. 3mm PBM Tip turn counter clockwise to remove it. Turn aluminum handpiece shell counter-clockwise to be removed.
PROCEDURAL RECOMMENDATIONS GUIDELINES The following procedure guidelines are provided as a guide only and have been developed based on information provided by experienced laser users and educators. Always review the patient’s history to evaluate possible contra-indication for use of local anesthesia or other complications. All clinical procedures performed with the Gemini EVO 810+980 soft tissue laser must be subjected to the same clinical judgment and care as with traditional techniques and instruments.
FACILITY & ENVIRONMENTAL CONSIDERATIONS GUIDELINES In addition to receiving proper training in the use of soft-tissue dental lasers, users should be familiar and experienced with these procedures using electrosurgical devices or traditional instruments before performing them on patients with the Gemini EVO 810+980 soft tissue laser.
GENERAL SAFETY CONSIDERATIONS GUIDELINES Safe use of the Gemini EVO 810+980 soft tissue laser is the responsibility of the entire dental team including the doctor, any system operators, and the dental office safety officer. In order to properly assess the favorable conditions of treatment, below is a pre-treatment checklist to help ensure treatment to your patient is safe: •...
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GENERAL SAFETY CONSIDERATIONS For more information see OSHA Technical Manual (TED1- 0.15A) Section III, Chapter 6, 1999. A safety program is recom- mended for the safety of your patients and office staff in connection with the use of the Laser. It is also recommended to check and comply with applicable state and provincial safety and health organization requirements.
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GENERAL SAFETY CONSIDERATIONS EMERGENCY SHUTDOWN OPTIONS: Perform any of these actions to terminate laser emissions in the event of a real or perceived emergency: Press the emergency “STOP” button. Press the “ON/OFF” button. ACTIVE STBY Remote Interlock open circuit deactivates the Laser Touch the ACTIVE/STBY Guided Touch Interface selection (Remote Interlock switch provided by request) Release your foot from the Activation Pedal...
SERVICE AND TROUBLESHOOTING CALIBRATION Re-calibration is recommended every 12 months in order to assure accuracy of optical output power. The Gemini EVO 810+980 soft tissue laser may be returned to the manufacturer for re-calibration, which you can arrange by contacting your distributor. Certain government or corporate entities may require calibration certificates which can also be provided by the manufacturer.
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SERVICE AND TROUBLESHOOTING TROUBLESHOOTING GUIDE Why is it difficult to see the red aiming light or why is it barely visible? CAUSE: 1. The laser is in STBY mode. 2. The aiming light under menu is turned off. 3. The fiber optic cable might be damaged or broken. SOLUTION: 1.
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SERVICE AND TROUBLESHOOTING TROUBLESHOOTING GUIDE My activation pedal is not working CAUSE: 1. Unit is not in ACTIVE MOVE. 2. I am ACTIVE but my Activation Pedal is not working. 3. Why is my Activation pedal vibrating? SOLUTION: 1. Make sure you select ACTIVE and tap the Activation Pedal once to wake it up. 2.
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SERVICE AND TROUBLESHOOTING ERROR MESSAGES An error message will flash where the Power Indicator is normally displayed. Software Update Fail The GEMINI EVO 810+980 Soft Tissue Laser is designed to perform periodic software updates. If during an update Internet connection is lost or unstable, the update may fail.
CYBERSECURITY OVERVIEW AND RECOMMENDATIONS The Gemini EVO 810+980 soft tissue laser has been developed with Cybersecurity integrated throughout the total-product- lifecycle. Activities such as threat modeling, requirements documentation, penetration testing, and post market management planning have been executed for the device. The Gemini EVO 810+980 soft tissue laser has been developed with Cybersecurity capabilities such as secure boot and code signing, using industry standard algorithms.
ELECTROMAGNETIC ENVIRONMENT GUIDANCE Electromagnetic Compatibility Notice: The Gemini EVO 810+980 soft tissue laser complies with all requirements for electromagnetic compatibility according to IEC 60601-1-2: 2014. CAUTION: Medical electrical equipment needs special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put into service according to the EMC information provided in the following tables.
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ELECTROMAGNETIC ENVIRONMENT GUIDANCE Definitions Emission (electromagnetic): When electromagnetic energy is emitted by a source. Interference Immunity: The ability of a device or system to work without errors even if there is electromagnetic interference. Immunity Level: The maximum level of a certain electromagnetic interference that affects a particular device or system, where the device or system remains operative with a certain level of performance.
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ELECTROMAGNETIC ENVIRONMENT GUIDANCE Interference Immunity The Gemini EVO laser is intended for operation in the electromagnetic environment specified below. The customer or user of the Gemini EVO laser should make sure that it is used in such an environment. INTERFERENCE IEC 60601-1-2 ELECTROMAGNETIC COMPLIANCE LEVEL...
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ELECTROMAGNETIC ENVIRONMENT GUIDANCE IEC 60601 ELECTROMAGNETIC IMMUNITY TEST COMPLIANCE LEVEL TEST LEVEL ENVIRONMENT GUIDANCE Conducted RF 3 Vrms 3 Vrms Portable and mobile radio equipment must not be IEC 61000-4-6 150 kHz to 80 MHz used within the recommended working clearance from the Gemini EVO laser and its cables, which is Radiated RF 3 V/m...
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ELECTROMAGNETIC ENVIRONMENT GUIDANCE WORKING CLEARANCES The Gemini EVO laser is intended for operation in an electromagnetic environment where radiated HF interference is checked. The customer or the user of the Gemini EVO laser can help prevent electromagnetic interference by duly observing the minimum distances between portable and/or mobile RF communication devices (transmitters) and the Gemini EVO laser.
3021 Citrus Circle - Suite 180 Walnut Creek, CA 94598 - USA 2797 1 (800)466-5273 Manufactured by EMERGO EUROPE ULTRADENT PRODUCTS, INC 505 West 10200 South EC REP Molenstraat 15 South Jordan, UT 2513 BH, The Hague 84095 - USA...
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LABELING HANDPIECE OPTICAL FIBER 18V / 3.6A EMERGENCY TERMINATION OF LASER EMISSIONS The Gemini EVO 810+980 soft tissue laser has been designed with several methods to terminate emission of laser energy in emergency situations. These methods include a power button (ON/OFF) and the emergency (STOP) button located at the front of the laser unit. ON/OFF STOP...
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LABELING SYMBOLS DESCRIPTION SYMBOLS DESCRIPTION MANUFACTURER SHIP VERTICAL, WITH ARROWS INDICATES WHICH COMPANY POINTED UPWARD MANUFACTURES DATE OF MANUFACTURE FRAGILE - HANDLE WITH CARE INDICATES THE DATE AND YEAR OF MANUFACTURE CATALOG PART NUMBER DO NOT USE IF PACKAGE IS INDICATES THE MANUFACTURER DAMAGED PART NUMBER.
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LABELING UNIT LABEL PEDAL LABEL AZENA MEDICAL, LLC 3021 Citrus Circle - Suite 180 Walnut Creek, CA ULTRADENT PRODUCTS, INC EMERGO EUROPE 94598 - USA AZENA MEDICAL, LLC 2797 1 (800)466-5273 EC REP 505 West 10200 South Molenstraar 15 3021 Citrus Circle - S-180...
WARRANTY Your Gemini EVO laser comes with a 2-year factory warranty. Extended warranty can be purchased and warranty certificates can be downloaded by accessing your Dashboard page at dashboard.geminievo.com or under the warranty icon in the iOS and Android Apps.
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U LT R A D E N T.COM Manufactured by Azena Medical, LLC. 3021 Citrus Circle, Suite 180, Walnut Creek, CA 94598 USA. Made in the USA of U.S. and imported components. Distributed by Ultradent Products Inc., 505 West Ultradent Drive, South Jordan, Utah 84095 1010000AR02 022322...
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